Proveca signs agreement with EMA to develop Glycopyrronium drug for children with sialorrhoea

NORTH West pharmaceutical company Proveca Limited has reached a key agreement with the European Medicines Agency (EMA) that will enable the development of a new drug designed for children and young people. 

The EMA’s Paediatric Committee (PDCO) adopted a positive opinion on the paediatric investigation plan (PIP) for the development of Glycopyrronium – a drug designed to combat chronic pathological drooling (sialorrhoea) in children.

Children living with motor or neurological disorders, such as cerebral palsy, are often unable to effectively swallow the saliva they produce resulting in unavoidable chronic drooling. Glycopyrronium will help to reduce this unintentional and disabling loss of saliva. 

The adoption of the PIP provides Proveca, based at Sci-Tech Daresbury in Cheshire, with an agreed programme for the future development of the drug. It will deliver the required quality, safety and efficacy data needed for the future authorisation of Glycopyrronium throughout Europe.

Dr Helen Shaw, director at Proveca Limited, said: “Incessant drooling associated with neurological disorders is out of the control of the person who suffers from it and can be an incredibly difficult issue to manage. Unfortunately, it is a symptom that comes with a number of associated health and hygiene implications, and can make a huge impact on a young person’s self-esteem and confidence. 

“As well as causing discomfort and irritation to the mouth and face, it can have profound effects on the digestive system, causes dehydration and increases the incidence of infection.” 

Co-director Simon Bryson added: “Glycopyrronium has the capability of making a huge improvement to the quality of life of those affected. Now that we have reached this milestone agreement with EMA, we are looking forward to a positive future and making this a reality for children and young people.”

Proveca is currently developing innovative medicines in the fields of cardiology, neurology and pain management, largely for young people. 

The PIP agreement with the EMA follows a successful 12 months for the company. This includes the appointment of Chris Brinsmead, the former president of Astra Zeneca UK, as chairman in September 2013. 

Proveca also secured a £2.6 million investment from Albion Ventures in December 2012 and a further £143,000 grant from Biomedical Catalyst, a joint programme from the Technology Strategy Board and Medical Research Council, in August 2013.